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COMPLETED Phase 2

PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients

NCT00948090 · View on ClinicalTrials.gov ↗

Study Summary

This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.

Conditions Studied

Interventions

  • DRUG IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)

Study Locations (20)

California

  • Alta Bates Summit Medical Center — Berkeley
  • Scripps Clinic — La Jolla
  • UCSD Medical Center BMT Program — La Jolla
  • Cedars-Sinai Medical Center — Los Angeles
  • Sutter Cancer Center — Sacramento
  • University of California, Davis Medical Center — Sacramento
  • University of California San Francisco Medical Center — San Francisco

Illinois

  • University of Illinois Cancer Center — Chicago
  • The University of Chicago — Chicago
  • Loyola University Chicago — Maywood

Alabama

  • University of Alabama in Birmingham — Birmingham

Arizona

  • Arizona Cancer Center — Tucson

Colorado

  • Rocky Mountain Cancer Centers — Denver

Florida

  • Florida Hospital Cancer Institute — Orlando

Georgia

  • Emory University — Atlanta

Indiana

  • Bone Marrow and Stem Cell Transplant Program — Indianapolis

Trial Details

FieldValue
Enrollment Target 207 participants
Start Date 2010-01
Est. Completion 2013-06
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00948090

The ClinicalTrials.gov registry entry for NCT00948090 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 1 intervention — of which IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00948090 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Illinois, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00948090 about?

NCT00948090 is a clinical study titled "PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients". This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.

What is the current status of trial NCT00948090?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2010-01. Estimated completion is 2013-06.

What conditions does trial NCT00948090 study?

This clinical trial studies the following conditions: Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00948090?

The interventions under investigation include: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00948090?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00948090 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial